Comparison Of The Analgesia Obtained By Infiltration For The Joinings Of Episiotomies (Liropep)

Childbirth Clinical Trial

— LiRoPep  

Official title:

Comparison Of The Analgesia Obtained By Infiltration Of Lidocaïne 1% And Ropivacaïne 0,75% Versus Placebo For The Joinings Of Episiotomies Among Parturients Under Epidural Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727935
• Other study ID #: CHU P 2006-03
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2008
• Last updated: August 4, 2008
• Start date: October 2006

Study information

• Verified date: August 2008
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Lateral episiotomy is a current care practiced with childbirth room. One of the problems encountered with this surgical act is the residual pain on perineal scar level. Maximal during the first 24 hours, this pain can persist several days or several weeks hampering to variable degrees a normal recovery of autonomy and comfort of life. Some studies have shown the interest of ropivacaine, local anaesthetic with a long action's duration for proctologic surgeries and for the cure of inguinal hernia. A recent study shown the ropivacaine perineal infiltration used prior perineorrhaphy allows an absence of post-partum pain for 24 to 27% of cases and a first analgesics request delayed to ten hours.

Methodology: 165 parturients having an epidural analgesia and an episiotomy were enrolled. The perineal infiltration was randomized according to 3 equal groups (placebo, ropivacaine 0,75%, lidocaine 1%) and realised prior perineorrhaphy. then The parturient were followed during the 24 first hours. This study was designed as double blind and the study conduct was standardized in order to get only variable such as the episiotomy infiltration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. primary completion date: July 2007
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Pre-inclusion criteria :

• Assent of participation in the study signed

• Major parturient (> 18 years) in the course of work in room of childbirth

• Mono-foetal pregnancy

• Presentation at the top

Inclusion Criteria:

• Checking of the criteria of pre-inclusion

• Oral confirmation of the assent of the patient

• ASA 1 or 2

• Childbirth by low way

• Patient having an epidural analgesia

• Patient having an episiotomy

• Counter-indication with the ropivacaïne

Pre-exclusion criteria :

• Absence of signed assent of participation in the study

• Counter indication with the lidocaïne

• General counter-indications suitable for the epidural anaesthesia , independently of the local anaesthetic used

• Counter-indications with the infiltration: patient under anticoagulants, coagulopathy

• Allergy to the lidocaine or the ropivacaine

• Allergy to the one of analgesics per bones used in the assumption of responsibility of routine

• Severe insufficiency hepatic and/or renal and/or ulcerates gastro-duodénal (in the case of anti-inflammatory drug regulation not steroid during the postpartum)

• Minor

• Major protected within the meaning of the law Huriet

• Patient during one time of exclusion following another biomedical study

Exclusion Criteria:

• Absence of oral confirmation of the assent of the patient

• Infection or ignition of the point of puncture

• Analgesia epidural not functional

• Dural breach

• Appearance of ascribable side effects to only the anaesthetic buildings at the time of epidural analgesia

• Median Episiotomy (increased risk of lesions of the sphincter)

• Need for an instrumentation at the time of expulsion

• Haemorrhage of the delivery requiring a blood transfusion and/or general anaesthesia in urgency with surgical operation for haemostasis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childbirth
• Parturients

Intervention

Drug:
• Lidocaïne

• Ropivacaïne

• Placebo

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Angers	Pays-de-la-Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between the infiltration of the local anaesthetic and the first analgesics catch per os, which is managed when the level of pain evaluated by EVA is higher than 30 mm		1 year
Secondary	To compare between the 3 groups the mean level of the pain during the first 24 hours following the joining of the episiotomy, measured by EVA		24 hours
Secondary	To compare between the 3 groups the analgesics overall consumption per os during the first 24 hours following the joining of the episiotomy		24 hours
Secondary	To compare between the 3 groups the total cost of the analgesics consumption (local anaesthetic employed and analgesics per bone) during the first 24 hours following the joining of the episiotomy		24 hours